MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 15" (38 CM) APPX 4.7 ML, BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE),; STOPCOCK, I.V. SET

Catalog Number CH3139

Device Problems Particulates (1451); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.

Event Description

The event involved a 15" (38 cm) appx 4.7 ml, bifuse add-on set w/2 bag spikes, 2 clamps (red, blue), plug adapter in which the customer reported that after the nurses prepare their lines by attaching the spike to the saline, then attaching the intravenous (iv) line, and when priming saline, plastic is noted within iv line chamber.When un-spiking the iv line, plastic is noted to be seen in spike hole at base of the device with iv line spike intact.The events were noted during priming.No medication was being used with the products.The other product used were several iv lines with list numbers: vlsp90, vlon72, vltr42 and vlst02 from fresenius kabi.There was no patient involvement, no harm was reported as a consequence of this event.This is report 2 of 2.

Manufacturer Narrative

Two new devices were returned for evaluation.As received, there was no particulate of any kind observed in any of the samples.No mating device was returned.The complaint of particulate matter cannot be confirmed based in the used physical sample evaluation.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - device received 6/12/2023.

• Brand Name: 15" (38 CM) APPX 4.7 ML, BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE),
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17099830
• MDR Text Key: 316896491
• Report Number: 9617594-2023-00232
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619024918
• UDI-Public: (01)00840619024918(17)261101(10)5675428
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CH3139
• Device Lot Number: 5675428
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IVLINES VLSP90/VLON72/VLTR42/VLST02/FRESENIUS KABI; SALINE, MFR UNK